PENTETATE CALCIUM TRISODIUM - Generic Drug Details

What are the generic drug sources for pentetate calcium trisodium and what is the scope of freedom to operate?

Pentetate calcium trisodium is the generic ingredient in two branded drugs marketed by Hameln and 3M, and is included in two NDAs. Additional information is available in the individual branded drug profile pages.

One supplier is listed for this compound.

Summary for PENTETATE CALCIUM TRISODIUM

US Patents:	0
Tradenames:	2
Applicants:	2
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	19
Clinical Trials:	1
Patent Applications:	202
What excipients (inactive ingredients) are in PENTETATE CALCIUM TRISODIUM?	PENTETATE CALCIUM TRISODIUM excipients list
DailyMed Link:	PENTETATE CALCIUM TRISODIUM at DailyMed

Recent Clinical Trials for PENTETATE CALCIUM TRISODIUM

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
National Cancer Institute (NCI)	Phase 1/Phase 2

See all PENTETATE CALCIUM TRISODIUM clinical trials

Pharmacology for PENTETATE CALCIUM TRISODIUM

Drug Class	Lead Chelator
Mechanism of Action	Lead Chelating Activity

US Patents and Regulatory Information for PENTETATE CALCIUM TRISODIUM

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
3m	YTTERBIUM YB 169 DTPA	pentetate calcium trisodium yb-169	INJECTABLE;INJECTION	017518-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Hameln	PENTETATE CALCIUM TRISODIUM	pentetate calcium trisodium	SOLUTION;INHALATION, INTRAVENOUS	021749-001	Aug 11, 2004		DISCN	Yes	No

PENTETATE CALCIUM TRISODIUM Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for PENTETATE CALCIUM TRISODIUM (Ca-DTPA)

Introduction

Pentetate calcium trisodium (Ca-DTPA) is a critical drug used for the treatment of internal contamination with radioactive materials such as plutonium, americium, and curium. Here, we delve into the market dynamics and financial trajectory of this essential medication.

Regulatory Approval and History

Ca-DTPA received its initial U.S. approval in 2004 for intravenous or inhalation administration to treat individuals with known or suspected internal contamination with plutonium, americium, or curium[3][4].

• The FDA's approval was based on extensive data, including a U.S. Registry of individuals with internal radioactive contamination and a review of published literature[1].

Market Demand

The demand for Ca-DTPA is niche but critical, primarily driven by the need for effective treatments in cases of nuclear accidents, occupational exposure, and other scenarios involving radioactive contamination.

• The market is not large in terms of volume but is significant in terms of the critical nature of the treatment it provides[1].

Competitive Landscape

Ca-DTPA and its counterpart, Zinc-DTPA (Zn-DTPA), are the primary chelating agents used for this specific indication. There are no direct competitors for the treatment of internal contamination with plutonium, americium, or curium.

• The market is dominated by a few pharmaceutical companies, with Hameln Pharmaceuticals GmbH being a key player due to its initial approval and ongoing production of Ca-DTPA[1][3].

Pricing and Reimbursement

Given the specialized nature of Ca-DTPA, the pricing is typically high due to the complexity of production, regulatory requirements, and the limited market size.

• The drug is usually covered by specialized insurance programs and government agencies, especially in cases of occupational exposure or public health emergencies[4].

Dosage and Administration

The dosage and administration protocols are strictly regulated:

• For adults and adolescents, a single 1.0 gram dose is administered intravenously.
• For children under 12 years, a dose of 14 mg/kg (not to exceed 1.0 gram) is recommended.
• Zn-DTPA is often used for maintenance therapy after the initial 24 hours if Ca-DTPA is not available[4].

Safety and Efficacy

Ca-DTPA has been found to be safe and effective when produced under approved conditions. However, it comes with specific warnings:

• Nebulized Ca-DTPA can exacerbate asthma.
• It can cause depletion of trace metals like zinc, necessitating monitoring of serum zinc levels and other parameters[2][4].

Financial Performance

The financial performance of Ca-DTPA is influenced by several factors:

• Production Costs: The drug's production involves complex processes and stringent quality control, which can be costly.
• Market Size: The limited market size due to the specialized nature of the treatment affects revenue.
• Government and Institutional Purchases: A significant portion of the revenue comes from government agencies and institutions that stockpile the drug for emergency use[1][3].

Future Outlook

The future outlook for Ca-DTPA is stable but with potential for growth in specific areas:

• Increased Global Preparedness: With growing concerns about nuclear safety and bioterrorism, there may be an increase in demand for stockpiling Ca-DTPA.
• Research and Development: Ongoing research into the use of chelating agents for other types of heavy metal contamination could expand the market[5].

Challenges and Opportunities

Challenges

• Regulatory Hurdles: Strict regulatory requirements can make it challenging to maintain and expand production.
• Limited Market Size: The niche market limits the potential for significant revenue growth.
• Side Effects and Monitoring: The need for careful monitoring of patients due to potential side effects adds to the complexity and cost of treatment[2][4].

Opportunities

• Expanding Indications: Research into using Ca-DTPA for other types of heavy metal contamination, such as gadolinium, presents new market opportunities[5].
• Global Health Initiatives: Participation in global health initiatives and emergency preparedness programs can increase demand and revenue.

Key Takeaways

• Ca-DTPA is a critical drug for treating internal contamination with radioactive materials.
• The market is niche but essential, driven by specialized needs.
• Regulatory approvals and strict production standards are crucial.
• The financial trajectory is influenced by production costs, market size, and government purchases.
• Future growth may come from increased global preparedness and expanding indications.

FAQs

Q: What is the primary use of Pentetate Calcium Trisodium (Ca-DTPA)?

A: Ca-DTPA is used to treat individuals with known or suspected internal contamination with plutonium, americium, or curium to increase the rates of elimination of these radioactive materials from the body[1][4].

Q: Who are the key players in the Ca-DTPA market?

A: Hameln Pharmaceuticals GmbH is a significant player due to its initial approval and ongoing production of Ca-DTPA[1][3].

Q: What are the potential side effects of Ca-DTPA?

A: Ca-DTPA can cause asthma exacerbation when nebulized and depletion of trace metals such as zinc. Monitoring of serum zinc levels and other parameters is necessary[2][4].

Q: How is Ca-DTPA administered?

A: Ca-DTPA is administered intravenously, with specific dosages for adults, adolescents, and children. Nebulized administration is also possible but with caution due to potential asthma exacerbation[4].

Q: What is the future outlook for the Ca-DTPA market?

A: The market is expected to remain stable with potential growth driven by increased global preparedness and research into new indications[1][5].

Sources

1. FDA: Questions and Answers on Calcium-DTPA and Zinc-DTPA (Updated)[1].
2. ORISE: Pentetate calcium trisodium injection (Ca-DTPA) package insert[2].
3. Federal Register: Determination That PENTETATE CALCIUM TRISODIUM (Trisodium calcium diethylenetriaminepentaacetate (Ca-DTPA)) solution for intravenous or inhalation administration[3].
4. Drugs.com: Pentetate Calcium Trisodium: Package Insert / Prescribing Info[4].
5. Investigative Radiology: Impact of Treatment With Chelating Agents Depends on the Stability[5].